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Bridgebio Pharma Announced Topline Results From CALIBRATE Phase 3 Study Of Encaleret In Autosomal Dominant Hypocalcemia Type 1, Meeting All Pre-specified Primary And Key Secondary Efficacy Endpoints

Author: Benzinga Newsdesk | October 29, 2025 06:11am

The CALIBRATE study of encaleret for patients with ADH1 met all pre-specified primary and key secondary efficacy endpoints.
The primary endpoint was met with 76% of participants administered encaleret achieving both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p<0.0001).
In a key secondary analysis, 91% of participants administered encaleret achieved intact PTH above the lower limit of the reference range at Week 24 compared to 7% of participants when on conventional therapy at Week 4.
Encaleret was well-tolerated with no discontinuations related to study drug
NDA submission planned in the first half of 2026 to support full approval
BridgeBio plans to initiate registrational studies of encaleret in chronic hypoparathyroidism and pediatric ADH1 in 2026

Posted In: BBIO